MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134702

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 02-apr-2024.The device evaluation was completed on 10-apr-2024.The device was returned to biosense webster for evaluation.A visual inspection, pump and pressure gage test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed that there was a big bent in the shaft close to the handle area.A pump and pressure gage test was performed and the catheter failed the test since the irrigation tube was found folded inside the shaft.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation issue reported by the customer was confirmed.The potential cause of the irrigation issue could be related to the bent in the shaft identified during the analysis.The instructions for use contain the following warning and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.Do not manually pre-shape the distal shaft of the catheter by applying external forces intended to bend or affect the intended shape or curve of the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the customer¿s reported irrigation issue.In addition, biosense webster inc.Analysis finding of the ¿bent in the shaft close to the handle area¿.Investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the customer¿s reported irrigation issue.In addition, biosense webster inc.Analysis finding of the ¿the irrigation tube folded inside shaft¿.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter and irrigation issue noted during device being used on the patient.The catheter would not power flush.The fluid was dripping from the irrigation ports of the catheter instead of spraying.They made sure the tubing was hooked up correctly but the issue persisted.They replaced the catheter and the procedure continued without further issues.Additional information was received on 25-mar-2024.The catheter is the suspected device for the reported flow / irrigation issue.The issue was noted during the device being used on the patient.Error on remote, temperature fault.Tried power flushing the catheter after readjusting the irrigation tubing with no resolve, so replaced catheter.Correct catheter settings were selected on the generator.Pump was switching from ¿low¿ to ¿high¿ flow during ablation.This event was originally considered non-reportable, however, bwi became aware of the irrigation issue noted during device being used on the patient on (b)(6) 2024 and have reassessed the event as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19140787
• MDR Text Key: 341462510
• Report Number: 2029046-2024-01299
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31220721L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE PUMP KIT-US; UNK_SMARTABLATE GENERATOR